Software Guidance & Assistance, Inc., (SGA), is searching for a Document Control Specialist for a Contract assignment with one of our premier Healthcare clients in Boston, MA.
Responsibilities :
Participates in global compliance and continuous improvement projects related to Quality System documentation.
Ensures compliance during QS documentation creation and revision and is accountable for content design and logistics of multi- and cross-functional documentation review and approval.
Supports development of strategy for creation of complex QS procedural documents involving cross-functional teams.
Ensures all administrative documentation requirements are met for supported Quality Documentation inclusive of document processing and records management.
Facilitates the creation/revision, administration, review, and approval (as applicable) of new and revised Quality Documentation within the Document Management System (DM)
Maintains notifications, relations, and other property information within the Document Management System (DMS).
Participates in supporting R&D project and initiatives and continuous improvement projects related to documentation management as applicable.
Supports and coordinates of document translation process (incl. Translation checking (LU only) as applicable.
Collects and reports documentation-related key performance indicator metrics.
Provide input into overall team strategy and framework development for new and emerging initiatives (incl. mid- and long-term team goals).
Required Skills:
Bachelor's degree (technical/scientific area preferred) or equivalent experience.Minimum 4+ years of pharmaceutical experience in a GMP environment administering Document Control Systems1-2 years' experience using and administering electronic document management tools.?